HRP Services
Program Enhancement
Organizations frequently self-identify areas for improvement, or become aware because of an audit, inspection, or accreditation review, but need recommendations or assistance to address the issues at hand. Leveraging the extensive experience and expertise of our HRP consultants and network of research professionals, we can help you identify and implement the best solution for your organization.
OHRP Issues Single IRB Draft Guidance
On July 1, 2022, OHRP posted a draft guidance document for public comment entitled “Use of a Single Institutional Review Board for Cooperative Research.” The draft guidance will be open for public comment until August 30, 2022. The recently posted draft guidance...
IND Safety Reports and IRBs
HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...